HPE 102 – Dec 2022 | Page 26

did not try any prior systemic therapy . This latter patient , whilst waiting for an appointment to commence ciclosporin , was admitted acutely to hospital with severe atopic dermatitis and started on dupilumab as this was deemed to be quicker acting with no need to wait for the necessary blood tests associated with immunosuppressive therapy .

Two patients who did not meet the reduction in EASI or in DLQI at review both had their treatment ceased . The drug cost impact of continuing inappropriate treatment in these two patients would be about £ 33,000 per year at NHS price and excluding VAT as these are provided via homecare . The actual cost impact is less than this due to the commercial arrangement in place .

A similar UK based study reported on 30 patients who received dupilumab after one or more immunosuppressive drugs . ¹¹ Their patients had average scores of 30 on EASI and 15 on the DLQI at baseline ( compared to our study values of 29.7 and 18.9 , respectively ). All their 30 patients showed adequate response at 16 weeks and therefore continued to receive dupilumab . They report a mean 70 % reduction in EASI after 16 weeks , and a 4-point or more reduction in DLQI for all the 30 patients . Of our 29 patients with a baseline EASI score , we saw at least a 70 % reduction in 26 patients , with a further 2 patients achieving the NICE requirement of at least a 50 % reduction and the one patient who did not achieve this reduction had therapy stopped . Two of our 30 patients did not meet the required DLQI score reduction . The patient who did not achieve the DLQI reduction had severe side effects from dupilumab and this would have adversely influenced the DLQI score . This patient with a poor DLQI response moved onto baricitinib as another option approved by NICE . ¹²

The reported results from our small study are not directly comparable with the major controlled trials for dupilumab which enrolled different groups of patients . SOLO1 and SOLO2 enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment . ⁵ LIBERTY AD CHRONOS included patients with moderate-to-severe atopic dermatitis and an inadequate response to topical corticosteroids . These patients were treated with topical corticosteroids as well as dupilumab or placebo . ⁶ LIBERTY AD CAFÉ included patients with a history of inadequate response or intolerance to ciclosporin , or for whom ciclosporin treatment was medically inadvisable . ⁷ For these trials , the Dupixent Summary of Product Characteristics reports on mean EASI score reductions at week 16 of approximately 72 %, 67 %, 80 % and 80 %, respectively . ¹³ Overall , we saw a 90 % reduction in EASI score for the 29 patients with both a baseline and review score .

Other real-world evidence has looked at efficacy and safety at 52 weeks . ^{14 , 15} These reports may have investigated different cohorts of patients and different efficacy measures , making direct comparisons difficult . Recognising that long-term ongoing treatment in patients with persistently controlled atopic dermatitis might lead to overtreatment and an increase in adverse events ( e . g ., injection site reactions , conjunctivitis ), there is some limited research into how tapering of dupilumab dosing should be undertaken . ¹⁶

As regards use of the EASI score : because this has moderate inter-observer reliability , it was suggested that the same investigator should perform the EASI in a patient at baseline and follow-up . ¹⁷ This does not always occur in our centre ; however , use of a tool such as EASI score . com ¹⁸ ( which has picture guidance ) helps to reduce the subjectiveness of the scoring process .

We recognise the limitations of a single centre , very small-scale retrospective study that sampled approximately 34 % of the patients recorded on Blueteq as having commenced dupilumab . We do not report prolonged follow up of patients in relation to any improvement in their atopic dermatitis other than what we observed documented in dermatology letters at commencement and review of treatment . These results therefore cannot be generalised to other hospitals .

Conclusion In this very small study , 28 of 30 patients were compliant with NICE criteria for commencing dupilumab in atopic dermatitis . Two patients who did not achieve the required improvement at the 16-week review and had their treatment ceased .

Declaration of interests : The authors have no interests to declare

KEY POINTS

• Dupilumab is indicated for the treatment of moderate to severe atopic dermatitis in adults who are candidates for systemic therapy .

• National Institute for Health and Care Excellence ( NICE ) technology appraisal guidance describes starting and stopping criteria in adults .

• In this retrospective study of dermatology correspondence , we found 28 of 30 patients were compliant with NICE criteria for commencing dupilumab in atopic dermatitis .

• Two patients who did not achieve the required improvement at the 16-week review and had their treatment ceased .

• Seeking assurance that this payment-by-results-excluded drug is used according to NICE guidance is important for the commissioners as well as internally for the hospital and the department .

26 | Issue 102 | hospitalpharmacyeurope . com